A Multicenter, Patient-Masked, Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
- Conditions
- Patients who participated in a previous intravitreal Brimo PS DDS study, including 190342-031D (Rhegmatogenous Macula-off Retinal Detachment).
- Registration Number
- EUCTR2010-019079-32-GB
- Lead Sponsor
- Allergan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 215
1. Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason
2. Written informed consent has been obtained
3. Written Authorization for Use and Release of Health and Research Study
Information (US sites only) has been obtained
4. Written Data Protection Consent (European sites only) has been obtained
5. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
6. Willing to follow instructions and likely to complete all required visits
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
n/a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the biodegradation and related safety profile of the intravitreal Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS®) Implant;Secondary Objective: n/a;<br> Primary end point(s): Safety Measures:<br> • Adverse events<br> • Vital signs (blood pressure, pulse, respiration)<br> • Manifest refraction and BCVA by ETDRS<br> • Biomicroscopic examination<br> • IOP<br> • Indirect ophthalmoscopic examination<br> • DDS® residual assessment<br> • Photograph of the implant if visible<br>
- Secondary Outcome Measures
Name Time Method